Kornimate/medical-research-clean huggingface dataset:
cleaner aspiration for pulmonary embolism

Conditions: Pulmonary Embolism; Acute Pulmonary Embolism; Cardiovascular Diseases; Venous Thromboembolism

Summary: to evaluate the safety and efficacy of the cleaner™ pro thrombectomy system for aspiration thrombectomy in patients with acute pulmonary embolism (pe).


Eligibility criteria:
inclusion criteria: * at least 18 years of age at the time of consent * clinical signs, symptoms, and presentation consistent with acute pe * onset of pe symptoms occurred within 14 days of presentation * filling defect in at least one main or lobar pulmonary artery evidenced by cta * rv dysfunction on cta or echocardiography defined as rv/lv ratio \>0.9 exclusion criteria: * tpa use within 14 days prior to baseline cta * systolic bp \<90 mmhg for 15 min or the requirement of inotropic support to maintain systolic bp ≥90 mmhg * diagnosis of pulmonary hypertension or suspected undiagnosed pulmonary hypertension with peak pa \>70 mmhg by right heart catheterization or elevated main pulmonary artery to aorta ratio (mpa:a) * history of severe or chronic pulmonary hypertension * fio2 requirement \>40% or \>6 lpm to keep oxygen saturations \>90% * hematocrit \<28% * platelets \<100,000/µl * serum creatinine \>1.8 mg/dl * inr \>3 * aptt (or ptt) \>50 seconds on no anticoagulation * history of heparin-induced thrombocytopenia (hit) * recent (within six months) history of stroke, transient ischemic attack (tia), or intracranial bleeding * recent (within one month) history of active bleeding from a major organ * absolute contraindication to anticoagulation * major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days * morbidly obese (bmi \>50 kg/m2) patient who by the judgement of the investigator is high risk for bleeding * presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * cardiovascular or pulmonary surgery within last 7 days * cancer which requires active chemotherapy * known serious, uncontrolled sensitivity to radiographic agents * life expectancy \<90 days, as determined by investigator * female who is pregnant * intracardiac thrombus * patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ecmo) or ecmo required to perform interventional procedure * simultaneous participation in another investigational study * patients with known coagulation disorders such as antiphospholipid, protein c, and protein s * presentation of pe with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization

Keywords: pulmonary embolism aspiration thrombectomy pe catheter directed thrombectomy
study on safety, absorption and metabolism of syha1402 tablets in healthy people

Conditions: Diabetic Neuropathy Peripheral

Summary: the trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. the trial planned to enroll sixty-two healthy volunteers. the subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.


Eligibility criteria:
inclusion criteria: 1. 18≤age≤45, male or female; 2. body weight (\> 45.0 kg (female) or 50.0 kg (male), 19.0 kg/m2 (\< bmi) = 26.0 kg/m2); 3. subjects with normal clinical significance by medical history, vital signs, physical examination and laboratory examination; 4. all subjects who adopt effective non-hormonal contraceptive measures (such as condoms, intrauterine devices without drugs, etc.) from the signing of informed consent to three months after the end of the study; 5. subjects who voluntarily signed the informed consent and are able to cooperate to complete the test according to the protocal. exclusion criteria: 1. female subjects: pregnant or lactating, or planned pregnancy; male subjects: their partner planned pregnancy, or planned to donate sperm; 2. have neurological or psychiatric diseases history, or have serious cardiovascular, liver and kidney, endocrine, respiratory, blood, digestive, immune and other systemic diseases history; 3. surgery history within six months before signing the informed consent; 4. allergic history to more than one drug or other serious allergic rhistory. 5. subjects with a qtc interval greater than 450 ms (male) or 470 ms (female), or with a history of prolonged qtc interval; 6. positive with serum immunological test for hbsag, anti-hcv, anti-hiv or anti-tp; 7. history of drugs or drug abuse or alcoholics; 8. history of blood donation more than 200 ml within 8 weeks before signing informed consent; 9. subjects participating in other clinical trials, or who have participated in any other clinical trials of drugs within three months before signing informed consent; 10. not suitable for this trial according to the investigator.
a phase 2 study evaluating efficacy, safety and tolerability of different doses and regimens of allocetra-ots for the treatment of organ failure in adult sepsis patients

Conditions: Sepsis; Community-acquired Pneumonia; Urinary Tract Infections; Cholecystitis, Acute; Cholangitis Acute; Intraabdominal Infections

Summary: a phase 2, multi-center, randomized, placebo-controlled, dose-finding study evaluating efficacy, safety and tolerability of different doses and regimens of allocetra-ots for the treatment of organ failure in adult sepsis patients

allocetra-ots is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. this is a multi-center, randomized, placebo-controlled, dose-finding study comparing the efficacy, safety and tolerability of different dosing regimens of allocetra-ots, in patients with sepsis. the study aims to compare the safety and efficacy of different doses and regimens of allocetra-ots, as well as the clinical manifestations following allocetra-ots treatment, to that of placebo in the treatment of organ failure in adult sepsis patients.

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years and ≤90 years of age. 2. meets sepsis 3 criteria with a sofa score ≥5 above pre-admission status 3. sepsis due to infection in at least one of the below organs: 3.1. community-acquired pneumonia (cap). 3.2. urinary tract infection 3.3. acute cholecystitis diagnosed by tokyo criteria 3.4. acute cholangitis diagnosed by tokyo criteria 3.5. other intra-abdominal infections (iai) 3.6. skin or soft tissue infection 4. adequate source control exclusion criteria: 1. sepsis due to infection other than lung infection, uti, iai, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown. 2. on chronic dialysis. 3. patients with acute pancreatitis 4. moribund patients 5. weight \ 120 kg or bmi \>40 kg/m\^2. 6. sofa score ≥14 at screening. 7. patients with nosocomial infection. 8. a known malignancy. 9. patients with end-stage disease (unrelated to sepsis) 10. known active symptomatic sars-cov-2 or chronic viral infections, such as hbv or hcv, hiv or other chronic infections. 11. chronic respiratory disease. 12. known active upper gi tract ulceration or hepatic dysfunction. 13. known nyha class iv heart failure or unstable angina, ventricular arrhythmias, acute coronary disease or myocardial infarction. 14. known immunocompromised state or medications known to be immunosuppressive. 15. organ allograft or previous history of stem cell transplantation.
protein supplementation to enhance exercise capacity in copd

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is a common smoking-related lung disease. pulmonary rehabilitation (pr) is a six-week supervised group exercise and education class. pr is an effective intervention in copd to reduce symptoms, improve exercise performance and prevent exacerbation. exercise intolerance/limitation is one of the commonest issues with copd patients and this may be compounded by reduced muscle mass and malnutrition. copd patients lose body weight and skeletal muscle mass which leads to muscle weakness and dysfunction, thus impacting functional ability and quality of life. muscle weakness is caused by a prolonged sedentary lifestyle and voluntary immobilization. importantly, being under-weight is associated with an increased risk of mortality in copd. nutritional supplementation have been used to overcome malnutrition in copd patients. it has been shown that nutritional support integrated with exercise training can improve exercise activity, decreased the risk of mortality, and improve muscle strength in undernourished copd patients. however, uptake of nutritional supplementation during pulmonary rehabilitation, where the potential benefit may be greatest, has been limited by the absence of rigorous evidence-based studies supporting use. investigators want to investigate the effect of a nutritional supplement during a pr program on exercise capacity in copd patients. investigators will collect demographic data, distribute questionnaires, measure exercise performance, and some additional measurements.


Eligibility criteria:
inclusion criteria: 1. confirmed copd (post-bronchodilator forced vital capacity in one second: forced vital capacity ratio \<0.7) 2. \>10 smoking pack year history. 3. enrolling on a pulmonary rehabilitation programme. 4. age of 18 and above. exclusion criteria: 1. patients with any physical or mental health disorders preventing compliance with trial protocol. 2. unable to communicate in english 3. malabsorption syndrome 4. unable to perform the incremental shuttle walk test 5. patients already using other types of oral dietary supplement, under the care of a dietitian. 6. galactosaemia (contraindication) 7. known cow's milk protein allergy or lactose intolerance 8. bmi \>30kg/m2 without recent weight loss of \>5%

Keywords: pulmonary rehabilitation nutrtional supplements
roles of vitamin d and hdl in obese children

Conditions: Obese; Vitamin D Deficiency; Low HDL

Summary: this is a pilot study to determine the association between vitamin d deficiency in obese children and low high density lipoprotein (hdl) and dysfunctional hdl.

subjects will be identified through the department of pediatric - high body mass index (bmi) clinic by dr. aurelia radulescu during standard of care visit. dr. radulescu will determine if the subject meets study eligibility requirements. visit 1 (baseline/screening): consent/assent will be obtained, medical history, demographic information along with height and weight will be collection. clinical laboratory testing, although not part of this study, will include the following standard of care tests. the results of vitamin d and lipid profile testing will be shared with dr. li by dr. radulescu. * lipid profile * vitamin d * ast/alt * hb a1c * glucose * cbs w/diff * tsh * bun, creatine * ua subjects will be placed on standard of care vitamin d supplementation for 12 weeks. visit 2 (3 month visit) end of study: subjects will return to the bmi clinic at month 3 for follow-up and additional clinical laboratory testing (see visit 1 for a description of testing to be performed) in order to assess their response to vitamin d supplementation. subjects with previously reported abnormal lipid values will have a lipid profile repeated at this visit. month 3 visit will be the end of study visit.

Eligibility criteria:
inclusion criteria: * obese children * vitamin d deficiency * low hdl exclusion criteria: * hiv * hepatitis a * hepatitis b * hepatitis c * non-english speaking

Keywords: obese children vitamin d deficiency low hdl
a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-ascending doses of bgb-16673 in adults with chronic spontaneous urticaria

Conditions: Chronic Spontaneous Urticaria

Summary: this study is a phase 1b, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics of multiple-ascending doses of bgb-16673 in adults with chronic spontaneous urticaria (csu).


Eligibility criteria:
inclusion criteria: * participants must be diagnosed with chronic spontaneous urticaria (csu) for ≥ 6 months before randomization. * the presence of itch and hives for ≥6 consecutive weeks at any time prior to randomization despite the use of second-generation h1-antihistamines * uas7≥16 and hss7≥8 during the 7 days before randomization * participants must not have had any missing uas7 entry (iss7 and hss7) during the 7 days before randomization * presence of hives must have been documented within 3 months before randomization exclusion criteria: * participants who have a clearly defined, predominating or sole trigger for their chronic urticaria (chronic inducible urticaria), including urticaria factitia (symptomatic dermographism) or cold, heat, solar, pressure, delayed pressure, aquagenic, cholinergic, or contact urticaria. * other diseases with symptoms of urticaria or angioedema * any other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results, eg, atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. * any uncontrolled disease state, including asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids. * significant bleeding risk or coagulopathy. * prior exposure to any btk inhibitors or protein degraders. note: other protocol defined inclusion/exclusion criteria may apply.
efficacy study of sargramostim in the retreatment of patients who have crohn's disease who have previously responded to treatment with sargramostim

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate whether treatment with leukine in patients with crohn's disease who have previously responded to leukine can be helped again, once they have relapsed.

on 29 may 2009, bayer began transitioning the sponsorship of this trial to genzyme. note: this study was originally posted by sponsor berlex, inc. berlex, inc. was renamed to bayer healthcare, inc.

Eligibility criteria:
inclusion criteria: * you must be 18 years or older. * you must have active crohn's disease at the time of screening. * you must be 18 years or older. * you must have active crohn's disease at the time of screening. * you must be able to give yourself an injection of study drug or have another person who can help you give the injection. * you must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential. exclusion criteria: * you may not be pregnant or breastfeeding. * you may not have a colostomy or ileostomy. * you may not be taking prohibited medications. * you may not have had gi surgery or a bowel obstruction in the last 6 months. * you may not have ever taken this drug or drugs of similar type in the past.

Keywords: crohn disease
observational longitudinal study on the outbreak and management of stroke related spasticity

Conditions: Spasticity as Sequela of Stroke

Summary: stroke is one of the leading cause of death and disability worldwide. post-stroke spasticity (pss) is outbreak after a stroke and is featured by disabling muscle stiffness. pss could manifest in up tp 50% cases within 6 months after a stroke, especially in the upper limb. despite it is an acknowledged condition it is insufficiently recognized and treated in clinical practice. focal and regional spasticity could improve with rehabilitation and in selected cases with botulinum neurotoxin (bont) type a injections. the latter causes muscle relaxation and fosters neuroplasticity, which is able in turn of ameliorating several patient functional aspects. recent literature demonstrated that pss patients treated with early bont (within 3 month since pss outbreak) could improve in their clinical status better than patients with a later treatment. an earlier recognition of pss predictors could improve patient management. hence, the investigators are going to perform a multicentric prospective observational real life study with bont, based on the best clinical practice and aimed at the early recognition and management of pss through the identification of 1) early clinical predictors of spasticity (collected within 10 days since stroke), 2) bont clinical outcome relative to the timing of the treatment


Eligibility criteria:
inclusion criteria: * ischemic stroke with onset not far than 10 days before the enrollment * bont naive * ability to sign the informed consent exclusion criteria: * hypersensitivity to bont or bont related substances * participant of post-stroke spasticity rct * persistent and severe altered mental status or concurrent severe medical condition able to hasten the rehabilitation path.

Keywords: botulinum neurotoxin type a (bont-a) stroke rehabilitation post-stroke spasticity (pss)
effects of high oleic palm olein, virgin olive oil and coconut oil diets on markers selected in malaysian

Conditions: Overweight

Summary: this study will be comparing human body responses by the effects of diets cooked with novelin, virgin olive oil and rbd coconut oil.

novelin has high content of monounsaturate fatty acids - oleic acid (c18:1) which is the predominant fatty acid and in this study novelin is used as cooking fat in compare with olive oil. olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83% oleic acid. consumption of olive oil gives numerous health benefits on lowering total and ldl cholesterol, reducing ldl cholesterol's, lowering blood clotting factors, and lowering blood pressure. coconut oil is the richest source of medium chain fatty acid and it has greater than 90% of saturated fatty acid with dominant fatty acid of lauric acid (c12:0). rbd coconut oil is used as positive control in this study.

Eligibility criteria:
inclusion criteria: * males and females aged 20-60 years * bmi 23 - 27.5 kg/m2 * free from any disease * not on any medication or treatment associated with reduction of cvd * non-smokers and non-heavy drinker or having smoking or alcoholic history * not pregnant or lactating * willing and able to comply exclusion criteria: * people on weight reduction therapy/program * people on cholesterol reduction medicatio * have one or more of the chronic diseases * people with blood clotting problem/ coagulopathy / deep vein thrombosis. * hypertensive persons (systolic pressure \> 140 mmhg, diastolic pressure \> 90 mmhg) * female who is pregnant * people travel to overseas during feeding.
transduction of sympathetic neural activity in human obesity without hypertension

Conditions: Obesity

Summary: in addition to chronically elevated msna, there is a growing recognition that hypertension in states of insulin resistance and obesity may also be attributed to an increased vascular sensitivity to msna (1, 2, 13, 36-38). to study this phenomenon, we quantify vascular sensitivity to msna using an innovative, moment-to-moment assessment of the blood pressure response following individual bursts of muscle sympathetic nerve activity (msna), (10, 11, 34, 37). this approach is termed 'sympathetic-vascular transduction (svt).' we will examine the hypothesis that svt is exaggerated in obesity and insulin resistance and is attenuated by suppression of oxidative stress. oxidative stress is the overabundance of reactive oxygen species and is another hallmark of hypertension, obesity, and insulin resistance. oxidative stress can be safely reduced via intravenous infusion of ascorbic acid (vit c) (4, 28). therefore, we will use a randomized, double-blinded, placebo-controlled approach to test the hypothesis that elevated svt will be attenuated by suppression of oxidative stress via ascorbic acid i.v. infusion compared with saline i.v. infusion (placebo) in obese adults with insulin resistance. our study will identify a unique mechanism that can be targeted to reduce the excessively high prevalence of hypertension and risk for cvd in obesity and insulin resistance.

this is a randomized, double blind, placebo-controlled study. eligible participants will have a total of 3 visits to the laboratory. at the first experimental visit individuals will be randomized in a double-blind fashion to either ascorbic acid or placebo and the alternative treatment will be given on the subsequent study visit. the ku investigational pharmacy will perform the blinded randomization. 1. week 1 visit 1 screening 2. week 2 visit 2 randomization and experimental visit 3. week 5 visit 3 experimental visit

Eligibility criteria:
inclusion criteria: 1. obese: bmi \>25 m/kg2 2. elevated insulin resistance: homa-ir \> 2.5 (calculation based on fasting glucose and insulin concentrations in blood) 3. middle-aged: 35-65 years 4. participants must be willing and able to discontinue taking any vitamin c or e supplements or omega-3 fatty acids beginning 2 weeks prior. 5. able and willing to provide written informed consent exclusion criteria: 1. currently taking a statin or antihypertension medication 2. hyperlipidemia: fasting triglycerides \< 250 mg/dl 3. hypertension: \>130/80 mmhg 4. history of heart disease (e.g., myocardial infarction, stent) 5. history of vascular disease (e.g., bypass, stroke) 6. individuals with narrow angle glaucoma -
abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer

Conditions: Prostate Cancer

Summary: to compare the safety of efficacy of abarelix versus goserelin plus bicalutamide in patients with advanced or metastatic prostate cancer.

inclusion criteria * males over 18 with documented advanced or metastatic prostate cancer outcome measures * comparative castration rates one week after starting therapy * degree of testosterone surge in the first month of treatment. * maintenance of medical castration during one year of therapy. * comparison of the treatments on qtc prolongation

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer and not previously treated with hormones * evidance of advanced disease or metastases * life expentancy of at least 3 months * normal serum testosterone levels * written informed consent exclusion criteria: * previous endocrine or cytoxic theapy for prostate cancer * known tumour complication of prostate cancer which owuld require immediate treatment * another malignancy other than basal cell cancer * history of significant drug hypersensitivity to either lhrh agonists or gnrh antagonists. * congenital or acquired coagulation disorders contraindicating intramuscular injections * pagets disease of the bone * qtcb \> 450 msec at day - 14

Keywords: prostate cancer advanced metastatic